3 replies to this topic

[Jean-C]

Could someone suggest: C/A , P measures for the following minors? Juust on side note, maintenance is almost done the fixing (i.e. immediate corrective action):

 

-The floor in the preparation area around the drain is found damaged; that could be difficult to clean

 

-Catch pan used to prevent oil leaks in the line 2 in the preparation area was observed with holes

 

-Equipment knives of the onion's peeler and removable knives in the processing area were noted rusty spots. As well as lubricant excess observed in the knives chain in the onion peeler.

 

 

Thanks 

Jean-C.

[MattQA]

CA should be to repair/replace. I also like to communicate to the stakeholders to say something if they see something that needs repair and why it is important in each case (other than the auditor says so). Preventive measure could be adding the areas to the internal audit or pre-op inspection.

 

These are just a couple possible solutions. A 5-whys analysis may provide deeper insight.

Edited by MattQA, Yesterday, 06:16 PM.

[TimG]

Afternoon Jean. You will want to discuss with your QandFS group and try to determine 'WHY' you missed these issues (or why you found them, but they didn't get addressed). Your CA should address WHY (root cause) you missed these items the auditor noted and then put something in place you feel will keep that from happening in the future. Rather it be frequency of inspections, more specific wording on your existing inspections, etc. 

I can't in good conscience spoon feed you the C/A or abatement measures, but I'd personally try to address these by making sure my internal GMP inspection or facility inspection is updated to include wording so the person doing the inspection is instructed to look for these and similar issues.

[Jean-C]

Thanks, you both Tim and Matt for your input.

Greatly appreciated !